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File: Production Pdf 154294 | Kos483 Drug Dosage Forms
rgas tehnisk universitte 16 01 2023 11 57 rtu course drug dosage forms 14a24 department of chemical technology of biologically active compounds general data code os483 course title drug dosage ...

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           Rīgas Tehniskā universitāte                                                                                                         16.01.2023 11:57
                                                                RTU Course "Drug Dosage Forms"
                                             14A24 Department of Chemical Technology of Biologically Active Compounds
           General data
           Code                                              ĶOS483
           Course title                                      Drug Dosage Forms
           Course status in the programme                    Compulsory/Courses of Limited Choice; Courses of Free Choice
           Responsible instructor                            Inese Mieriņa
           Academic staff                                    Māra Jure
           Volume of the course: parts and credits points    1 part, 2.0 Credit Points, 3.0 ECTS credits
           Language of instruction                           LV, EN
           Annotation                                        The study course provides students with in-depth knowledge of the basic rules of industrial
                                                             production of pharmaceutical dosage forms and good manufacturing practice, the characteristics of
                                                             different drug dosage forms and the basic principles of development/production processes, quality
                                                             assessment of drug dosage forms, biopharmaceuticals. The study course examines the interaction
                                                             between drugs and food, active substances and excipients. Students are given an insight into the
                                                             most important drug dosage forms: hard dosage forms (powders, granules, tablets), aerosols, soft
                                                             (ointments, creams, gels, rectal dosage forms, patches) and parenteral dosage forms, dispersed
                                                             systems (suspensions, emulsions), gelatine capsules and the specifics of their production.
           Goals and objectives of the course in terms of    The goals of the study course: to provide basic knowledge about the main principles of design and
           competences and skills                            development of various drug dosage forms in pharmaceutical industry, the role and application of
                                                             various excipients in the development of dosage forms, quality assessment of dosage forms,
                                                             application of biopharmaceutical research in vitro in development of dosage forms.
                                                             The objectives of the study course: to provide competence in the basic principles of development
                                                             and manufacturing of various drug dosage forms, knowledge of good manufacturing practice in
                                                             pharmaceutical production, to develop abilities and skills to choose the most appropriate dosage
                                                             forms depending on active pharmaceutical ingredient and drug pathway.
           Structure and tasks of independent studies        Preparation for three tests (solid dosage forms, dosage forms for parenteral administration dosage
                                                             forms for parenteral administration, semisolid dosage forms).
           Recommended literature                            Obligātā/Obligatory:
                                                             1. European Pharmacopoeia 6.0 vol.1, vol.2., Supplements 6.1., 6.2., 6.3., 6.4., 6.5., 6.6., 6.7., 6.8.
                                                             2. European Pharmacopoeia 7.0 vol.1, vol.2.  Supplements 7.1. – 7.4.
                                                             3. USP - U. S. Pharmacopoeia 23, 1995.
                                                             4. British Pharmacopoeia 1993, vol. I, II.
                                                             5. DAB 10 -  Deutsches Arzneibuch 10, 1994. Band 1 – 4.
                                                             6. Homöopathisches Arzneibuch 5 Nachtrag 1991.
                                                             Papildu/Additional:
                                                             7. Analysis of drug impurities / ed. by R.J.Smith, M.L.Webb. Oxford; Ames, Iow: Blackwell,
                                                             2007.
                                                             8. Nanomedicine for drug delivery and therapeutics / ed. by Ajay Kumar Mishra. Beverly, MA:
                                                             Scrivener Publishing, Wiley, 2013.
                                                             9. M.J.Groves. Parenteral Technology  manual. USA, 1989.
                                                             10. Sterile Pharmaceutical Manufacturing. Ed. by  M.J.Groves, W.P.Olson, M.H.Anisfeld. Vol. 1.
                                                             – 2., 1990, USA.
                                                             11. Pharmaceutical salts and co-crystals / ed. by J.Wouters, L.Quéré. Cambridge, UK: RSC
                                                             Publishing, 2012.
                                                             12. Liebermann H.A., Lachman L., Schwartz J.B. Pharmaceutical dosage forms, Tablets. Vol. 1,
                                                             Vol. 2, Vol. 3. New York. Mardel Dekker Inc. 1992.
                                                             13. Handbook of Pharmaceutical Exipients. 4th Edition. Ed. by R.C.Rowe, P.J.Sheskey,
                                                             P.J.Weller., 2003.
                                                             14. Pharmaceutics. The science of dosage form design. Ed.by M.E.Aulton, 2002.
                                                             15. Pharmaceutical capsules. Ed. by Fr.Podezeck, B.E.Jones, 2004.
                                                             16. Encyclopedia of Pharmaceutical technology. 3rd ed., 6 Volume Set.
                                                             17. Fiedler Encyclopedia of Excipients for Pharmaceuticals, Cosmetics and Related Areas. 6th ed.
                                                             Ed. E.M. Hoepfner, S.Lang, A.Reng, P.C.Schmidt. Vol. 1, Vol. 2, 2007.
                                                             18. Allen, Loyd V. Ansel's pharmaceutical dosage forms and drug delivery systems / Loyd V.
                                                             Allen, Jr., Howard C. Ansel, PhD. Philadelphia : Wolters Kluwer Health, 2014.
                                                             20. Pharmaceutical dosage forms and drug delivery / Ram I. Mahato, Ajit S. Narang. Boca Raton,
                                                             FL: CRC Press, 2012.
                                                             21. Essentials of pharmaceutical chemistry / ed. by D.Cairns. London; Chicago: Pharmaceutical
                                                             Press, 2012.
                                                             22. Zāļu un uztura mijiedarbība un blaknes / A.Skutelis, I.Bārene. Rīga: Medicīnas apgāds, 2013.
           Course prerequisites                              Knowledge of organic synthesis and biological chemistry.
           Course contents
           Content                                                                                                 Full- and part-time     Part time extramural
                                                                                                                    intramural studies           studies
                                                                                                                   Contact      Indep.     Contact      Indep.
                                                                                                                    Hours       work        Hours       work
           Dosage forms. Obtaining, investigation of physical, chemical, pharmacologycal and toxicologycal            2           2           0           0
           properties of active substances. Excipients. Composition of dosage forms. Packing materials
           Assessment of quality of dosage forms. European Pharmacopoeia. Regulations. Validation of                    2           2           0           0
           methods of analyses. Studies of stability, shelf-life
           Good manufacturing practice (GMP) and it importance for manufacturing of qualitative medicine.               2           2           0           0
           GMP for starting materials
           Solid dosage forms. Technology and standartization of powders. Preparing and quality assessment              2           2           0           0
           of granules
           The characterization of quality of tablets, assortment of excipients. The process of manufacturing of        2           2           0           0
           tablets. Coating
           Capsules - types and characterization. Manufacturing methods of gelatine capsules. Filling the               2           2           0           0
           powders, oils and other solutions in the gelatine capsules
           Aerosols. The characterization and classification of aerosols. The characterization of containers for        2           2           0           0
           aerosols and propellants; technology and assessment of quality
           Dispersion systems. Emulsions and suspensions. Assortment of surfactants (emulsifying agents).               2           2           0           0
           Manufacturing and standardization of emulsions and suspensions
           Soft dosage forms. The characterization and assortment of excipients of ointments, creams, gels,             2           2           0           0
           pastes. Technology and assessment of quality of ointments, creams, gels and pastes
           The characterization of the rectal and vaginal drugs. Excipients and vehicles (suppository bases)            1           2           0           0
           The classification and assortment of plasters. The characterization of excipients is used in plasters        1           2           0           0
           technology. Technology and assessment of quality of plasters
           Solutions and liquids. The characterization of solvents used for preparation of solutions. Water             2           2           0           0
           purification. Technology of preparation and quality assessment of water and non-aqueous solutions
           Parenteral preparations and their quality requirements. Glass and plastic containers for parenteral          2           2           0           0
           preparations. Organic and other solvents used for preparation of injection solutions.
           The process of technology of parenteral preparations and assessment of their quality. Methods of             2           2           0           0
           sterilization. Dosage forms for treatment of eye diseases
           Biopharmaceutics. The mechanism of drug absorption. The factors influencing the dissolution                  1           2           0           0
           process and absorption of active substances. Methods of bioavailability assessment.
           Interaction of food and drugs. The food influence on the bioavailability of drugs – (dissolution,            1           2           0           0
           absorption, transport and excretion).
           Test Nr. 1: Solid drug dosage forms.                                                                         1           4           0           0
           Test Nr. 2: Parenteral drugs.                                                                                1           4           0           0
           Test Nr. 3: Soft drug dosage forms.                                                                          1           4           0           0
           Final test.                                                                                                  1           4           0           0
                                                                                                            Total:     32          48           0           0
           Learning outcomes and assessment
           Learning outcomes                                                                                       Assessment methods
           Is familiar with the legislation of pharmaceutical production and the registration of drug dosage       Form of examination: tests; final test.
           forms.                                                                                                  Criteria: the student knows and understands
                                                                                                                   the legal requirements to be fulfilled in the
                                                                                                                   pharmaceutical production of drug dosage
                                                                                                                   forms, knows the course, requirements and
                                                                                                                   terminology of registration of drug dosage
                                                                                                                   forms.
           Knows the advantages and disadvantages of different dosage forms of drugs, the main principles of       Form of examination: tests; final test.
           their selection depending on the specific API and the way they are administered.                        Criteria: the student is able to choose the most
                                                                                                                   appropriate dosage form of the drug
                                                                                                                   depending on the method of its
                                                                                                                   administration.
           Knows the technologies of production of various drug dosage forms and quality control, is able to       Form of examination: tests; final test.
           communicate with other production specialists: pharmacists, technologists and analysts.                 Criteria: the student knows and is able to
                                                                                                                   choose the most appropriate technologies and
                                                                                                                   quality control methods for the production of
                                                                                                                   dosage forms, is able to solve specific
                                                                                                                   production problems.
           Is able to choose a ready-made and optimal form of the drug.                                            Form of examination: tests; final test.
                                                                                                                   Criteria: the student is able to solve the given
                                                                                                                   task by choosing the most optimal drug
                                                                                                                   dosage form for a particular pharmaceutical
                                                                                                                   product.
           Evaluation criteria of study results
           Criterion                                                                                                                                 %
           Test Nr. 1: Solid drug dosage forms                                                                                                       25
           Test Nr. 2: Parenteral drugs                                                                                                              25
           Test Nr. 3: Soft drug dosage forms                                                                                                        25
           Final test                                                                                                                                25
                                                                                                                                  Total:            100
           Study subject structure
             Part      CP                     Hours per Week                                     Tests                              Tests (free choice)
                                   Lectures       Practical         Lab.           Test         Exam           Work          Test          Exam          Work
              1.       2.0           2.0             0.0             0.0             *                                         *
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...Rgas tehnisk universitte rtu course drug dosage forms a department of chemical technology biologically active compounds general data code os title status in the programme compulsory courses limited choice free responsible instructor inese mieria academic staff mra jure volume parts and credits points part credit ects language instruction lv en annotation study provides students with depth knowledge basic rules industrial production pharmaceutical good manufacturing practice characteristics different principles development processes quality assessment biopharmaceuticals examines interaction between drugs food substances excipients are given an insight into most important hard powders granules tablets aerosols soft ointments creams gels rectal patches parenteral dispersed systems suspensions emulsions gelatine capsules specifics their goals objectives terms to provide about main design competences skills various industry role application biopharmaceutical research vitro competence develo...

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